None listed
Conditions
Brief summary
Evidence suggests that fragmented REM sleep may serve as a likely mechanism by which insomnia increases the risk for PTSD. To test this, project ARISE examines the role of REM sleep in trauma recovery mechanisms in individuals with insomnia disorder. The study aims to: 1) examine the relationship between REM sleep and fear inhibition (extinction and safety signal recall) in insomnia disorder; and 2) test whether improving REM sleep through treatment of insomnia, subsequently improves measures of fear inhibition. This study will be the first to examine REM fragmentation as a potential mechanism underlying insomnia's contribution to PTSD. It will have potential significant implications for the prevention of PTSD, as well as other disorders characterised by impaired fear inhibition (i.e., most anxiety disorders), in populations at risk for trauma exposure (e.g., emergency service workers) and/or REM fragmentation (e.g., other sleep disorders, shift work etc.).
Interventions
Participants will be randomised to either an active treatment or waitlist control condition.
Participants randomised to the active treatment condition will immediately receive 7 weekly treatment sessions of Cognitive Behavioural Therapy for Insomnia (CBTI), following their pre-treatment testing phase. This will be delivered via telehealth (i.e., via Zoom) with a trained clinician. Each treatment session will last approx. 1 hour and will take the format of individual, one-on-one sessions (i.e.,
Participants will be randomised to either an active treatment or waitlist control condition. Participants randomised to the active treatment condition will immediately receive 7 weekly treatment sessions of Cognitive Behavioural Therapy for Insomnia (CBTI), following their pre-treatment testing phase. This will be delivered via telehealth (i.e., via Zoom) with a trained clinician. Each treatment session will last approx. 1 hour and will take the format of individual, one-on-one sessions (i.e., one clinician per client). Throughout the 7-week intervention period, participants will be asked to wear an actigraph/fitbit 24-hours per day (except when engaged in activities that may damage the device). Participants will also be asked to complete a daily sleep diary throughout the treatment program and to practice 1-3 strategies learnt in session in between therapy sessions. Ideally, these strategies are used daily. The Intervention: CBTI is the current gold-standard treatment for insomnia, and a multicomponent intervention. Clinicians will work with clients to help them make changes to their sleep-wake patterns, to improve sleep. This includes setting regular sleep and wake times, getting out of bed when one is unable to sleep, sleep restriction and stimulus control. CBTi also addresses common misconceptions about sleep and unhelpful thought patterns, which may be perpetuating sleep problems. Finally, CBTi includes education about improving the sleep environment and relaxation techniques. Clinicians: Sleep clinicians will be registered provisional psychologists, trained by Chief Investigator, Prof Drummond, who has clinical expertise in treating behavioural sleep disorders such as Insomnia Disorder. Clinicians will be trained using methods based on those recommended by leading experts in the field. Fidelity: All clinicians will be regularly evaluated to ensure they are delivery the intervention properly. All treatment sessions will be recorded over Zoom. Every session from the first two cases of each treatment and 10% of all subsequent sessions will be evaluated by a registered psychologist trained in CBT-I for treatment fidelity (based on standardised check lists of session content). All recordings will be securely stored, kept highly confidential, and only accessed by the research team for the purpose of fidelity checks. Adherence: Adherence to treatment will be monitored throughout the intervention via the daily sleep diary, and a weekly adherence questionnaire administered by the clinician. This questionnaire was designed by the investigators to gauge the individual’s adherence to 7 specific CBT-I activities (e.g., completing sleep diaries, stimulus control etc.) each week.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
a) Insomnia Disorder b) 18-70 years of age c) Fluent in English d) Full vaccination status (COVID-19)
Exclusion criteria
a) Unmanaged sleep disorders other than insomnia and extreme chronotypes b) History of night or early morning shift work in the past 3 months or transmeridian travel (greater or equal to 2 time zones) in the past 2 months c) Current behavioural treatment for insomnia (or within past month) d) Major mental health condition(s) known to affect REM sleep or fear inhibition e) Major physical health condition(s) f) Current Substance Use Disorder (including Alcohol Abuse), frequent cannabis use or other recreational drug use g) Current use or recent discontinuation of medications known to affect REM sleep or fear inhibition. These include, SSRIs/SNRIs, tricyclic antidepressants, opiates, orexin antagonists, benzodiazepines, hypnotics, corticosteroids and ADHD medication (methylphenidate, amphetamine etc). Participants may be eligible to participate if the drug has been safely discontinued for a minimum duration equivalent to 5 half-lives of the drug. h) Failure to exhibit a consistent startle response on day of screening (i.e., over 75% discernible response to six 108-dB 20ms startle pulses), as a normal startle response is necessary to measure fear inhibition via the fear potentiated startle task we will use. i) Failure to respond to a 35 dB pulse at 500, 1000 and 3000 Hz in both ears when tested via an audiometer. j) Age above 70 years, as this group has been shown to exhibit diminished startle responses and fear conditioning rates. Normal startle responding and fear conditioning rates are required for the paradigm used to test one of the main outcomes of interest (i.e., fear and safety recall in the fear-potentiated startle task). k) Living with a children under 1 year of age, as they impact sleep. l) Currently pregnant or breastfeeding, or actively trying to conceive. Major changes in sex hormones during these stages are likely to affect fear conditioning and extinction measures. m) Any current treatments involving sex hormones (e.g., gender-affirming hormone treatments, fertility treatments), with the exception of birth control and hormone replacement therapies (e.g., estrogen replacement therapy in peri/postmenopausal women) if the participant has been on a stable dose for at least 3 months. If the participant has just come off hormone replacement therapy, a period of 3 months for hormones to re-stabilise is required before study participation. n) Hot flashes which are frequent or cause significant interference with sleep o) Any other factor that the researcher determines will affect study outcome. In-treatment exclusions: a) Hospitalisation b) Taking >10 weeks to complete the 7-week treatment program.
Outcome results
None listed